Efficacy of Mazdutide on Fatty Pancreas
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTongji Hospital
About this trial
This is a randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial designed to evaluate the efficacy and safety of mazdutide in improving fatty pancreas in patients with overweight or obesity. The study plans to enroll 194 participants with overweight or obesity, who will be randomly assigned in a 1:1 ratio to either the mazdutide plus standardized lifestyle intervention group or the placebo plus standardized lifestyle intervention group, for a treatment duration of 48 weeks. The primary efficacy endpoint is the change from baseline in pancreatic proton density fat fraction (PDFF) measured by MRI at week 48. Secondary efficacy endpoints include changes in body weight, body mass index (BMI), waist circumference, glycemic and lipid metabolic parameters, visceral fat, and hepatic fat content. This study aims to provide preliminary evidence-based data supporting the application of mazdutide in the treatment of fatty pancreas associated with metabolic dysfunction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 years (inclusive) at screening, regardless of gender;
BMI at screening meets one of the following conditions: ① BMI ≥28 kg/m²; or ② 24 kg/m² ≤ BMI <28 kg/m², with at least one obesity-related metabolic abnormality (elevated fasting blood glucose, dyslipidemia, hypertension, etc.);
Pancreatic MRI-PDFF quantitative assessment completed during the screening period, with intrapancreatic fat deposition (IPFD) ≥6%;
Fully informed about the study and voluntarily signed written informed consent;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
mazdutide
DrugOn the basis of standardized lifestyle intervention, patients received mazdutide injection (prefilled auto-injector pen) via weekly subcutaneous injection (abdominal), following a dose-escalation regimen: an initial dose of 2 mg for weeks 1-4, escalation to 4 mg for weeks 5-8, and a maintenance dose of either 4 mg or 6 mg starting from week 9 (determined by tolerability and efficacy), with a treatment duration of 48 weeks.
Placebo matching mazdutide
Other interventionOn the basis of standardized lifestyle intervention, patients received a placebo injection identical to mazdutide injection in appearance, volume, and administration route, via weekly subcutaneous injection (abdominal), with a treatment duration of 48 weeks.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage change in Intrapancreatic Fat Deposition (IPFD) from baseline
The relative percentage change in IPFD measured by pancreatic MRI-PDFF at Week 48 compared to baseline, calculated as: \[(IPFDatWeek48-BaselineIPFD)/BaselineIPFD\] × 100%.
Time frame
From baseline to Week 48Secondary outcomes
1
Change in visceral fat area
Absolute change in visceral fat area (measured by MRI or CT, as per protocol specification) from baseline.
Time frame
From baseline to Week 482
Change in Body Mass Index (BMI)
Absolute change in BMI (kg/m²) from baseline.
Time frame
From baseline to Week 483
Change in body weight
Absolute change in body weight (kg) from baseline.
Time frame
From baseline to Week 484
Change in waist circumference
Absolute change in waist circumference (cm) from baseline.
Time frame
From baseline to Week 48Sponsors and contacts
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Source ClinicalTrials.gov
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